Regulation - Asia-Pacific

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201 to 225 of 248 results

Business in Japan versus to Japan, by P Reed Maurer

11-06-2012

A pharmaceutical company without a presence in Japan but with a hot new product ready for Phase III clinical…

Asia-PacificBiotechnologyMarkets & MarketingPharmaceuticalRegulation

NZ's PHARMAC consults on funding for Iressa and Tarceva

31-05-2012

The Pharmaceutical Management Agency of New Zealand, PHARMAC, is seeking feedback on a proposal to:

Asia-PacificAstraZenecaIressaOncologyPharmaceuticalPricingRegulationRocheTarceva

Australia's TGA launches consultation on better medicines labeling

24-05-2012

Australia's medicine's regulator, the Therapeutic Goods Administration, has this week released a consultation…

Asia-PacificBiotechnologyGenericsPharmaceuticalRegulation

Impact of Japanese drug price reductions, by P Reed Maurer

10-05-2012

Outside observers have long predicted the mandated price reductions of drugs will kill the Japanese pharmaceutical…

Asia-PacificPharmaceuticalPricingRegulation

New Zealand considers listing of NovoMix 30 and NovoSeven RT and amendment for Glucagen Hypokit

02-05-2012

The Pharmaceutical Management Agency of New Zealand, PHARMAC, is seeking feedback on a proposal to fund…

Asia-PacificDiabetesGlucaGenNovo NordiskNovoMixNovoSevenPharmaceuticalPricingRegulation

Arzerra and ospemifene NDAs submitted in Japan

02-05-2012

UK pharma giant GlaxoSmithKline (LSE: GSK) and Danish company Genmab A/S (OMX: GEN) have submitted a…

ArzerraAsia-PacificGenmabGlaxoSmithKlineOncologyospemifenePharmaceuticalQuatRx PharmaRegulationShionogiWomen's Health

Indian government task force makes recommendations to curb drug counterfeiting

15-04-2012

Last week, a high-level task force on pharmaceutical manufacturing recommended the adoption of unique…

Asia-PacificPharmaceuticalRegulation

Actelion drops setipiprant, gets miglustat approval in Japan

04-04-2012

Switzerland-based Actelion Ltd (SIX: ATLN) announced says that it will re-direct its development efforts…

ActelionAsia-PacificBiotechnologyBrazavesInflammatory diseasesMiglustatRare diseasesRegulationResearchsetipiprantZavesca

Daiichi Sankyo files denosumab in Japan for osteoporosis

26-03-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) revealed on Friday that it has filed for approval in Japan…

AmgenAnti-Arthritics/RheumaticsAsia-PacificDaiichi SankyodenosumabPharmaceuticalRegulation

New Zealand approves Effient listing for clopidogrel-allergic patients

19-03-2012

The Pharmaceutical Management Agency of New Zealand, PHARMAC, has announced reaching agreement with US…

Asia-PacificCardio-vascularEffientEli LillyPharmaceuticalPricingRegulation

Sihuan Pharma heart drug IND accepted in China

12-03-2012

Leading China-based cardio-cerebral vascular drug firm Sihuan Pharmaceutical Holdings (HKEx: 0460) says…

Asia-PacificCardio-vascularMarkets & MarketingPharmaceuticalRegulationSihuan Pharmaceuticaltylerdipine

Australia latest to approve Bayer's Eylea

08-03-2012

The Australian Therapeutic Goods Administration (TGA) has approved Eylea (aflibercept) Injection for…

Asia-PacificBayerEyleaOphthalmicsPharmaceuticalRegeneronRegulation

New Zealand to fund new cancer drugs Tykerb and Votrient

05-03-2012

The Pharmaceutical Management Agency of New Zealand, PHARMAC, says it is funding two new targeted cancer…

Asia-PacificGlaxoSmithKlineOncologyPharmaceuticalPricingRegulationTykerbVotrient

Frontage and Fanghui Pharma launch $10 million collaboration

28-02-2012

Emerging Chinese pharmaceutical company Luohe Fanghui Pharmaceutical has launched a new globalization…

Asia-PacificFanghui PharmaceuticalsFinancialFrontage LaboratoriesGenericsNorth AmericaRegulation

Access Pharma’s MuGard OKed in China

26-02-2012

USA-based specialist in supportive care for cancer patients Access Pharmaceuticals (OTCBB: ACCP) revealed…

Access PharmaceuticalsAsia-PacificJain An PharmaceuticalsMuGardOncologyPharmaceuticalRegulationRhei Pharmaceuticals

Additional indications in Japan for Diagnogreen and Sawacillin

22-02-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) says it has received approval in Japan for a supplemental…

Antibiotics and Infectious diseasesAsia-PacificAstellas PharmaDaiichi SankyoPharmaceuticalRegulationSawacillin

Nine news Rx drugs added to Australian PBS listings

22-02-2012

Australia’s Federal Minister for Health, Tanya Plibersek, yesterday announced the listing of nine…

Asia-PacificAstraZenecaBrilintaGlaxoSmithKlinePharmaceuticalPricingRegulationZinnat

Proposal to fund Lilly’s Effient in New Zealand

21-02-2012

PHARMAC, the Pharmaceutical Management Agency of New Zealand, is seeking feedback on a proposal to fund…

Asia-PacificEffientEli LillyPharmaceuticalPricingRegulation

Department of Justice seeks permanent injunction against Ranbaxy

27-01-2012

The US Department of Justice, on behalf of the Food and Drug Administration, has filed a consent decree…

Asia-PacificGenericsLegalNorth AmericaRanbaxy LaboratoriesRegulation

Overview of biologic regulations in India

26-01-2012

Currently, all biologics in India, including innovative and copy biologics are approved as new drugs,…

Asia-PacificBiotechnologyGenericsRegulation

Additional indication for Otsuka’s Abilify in Japan

22-01-2012

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) said last week that it has received new regulatory…

AbilifyAsia-PacificNeurologicalOtsukaPharmaceuticalRegulation

Eisai gets Lunesta approval in Japan, launches Fostoin

20-01-2012

Japanese drug major Eisai (TYO: 4523) this week received approval from Japan's Ministry of Health, Labor…

Asia-PacificEisaiFostoinLunestaMarkets & MarketingNeurologicalNobelpharmaPharmaceuticalRegulation

Drug approval and launch for Novartis in China, where Quintiles expands

18-01-2012

Swiss drug major Novartis (NOVN: VX) says it has received regulatory approval in China from the State…

Asia-PacificDiabetesGalvusLucentisMarkets & MarketingNovartisOphthalmicsPharmaceuticalQuintilesRegulationResearch

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